MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® C. DIFFICILE GDH

Catalog Number 30125

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

On (b)(6) 2022, a customer from (b)(6) reported to biomérieux that they observed negative results when testing patient sample with vidas gdh 60 tests (ref.30125, batch 1009166990 expiry date 22-feb-2023) compared to another method.The customer performed test on one patient sample and he obtained a negative result.He compared with another method (pcr), he obtained a positive result.Patient history: man of 82 years old with colitis & chronic myeloid leukemia.The customer stated there is a delay in rendering result of 4 days.There is no indication or report from the laboratory that the issue led to any adverse event related to patient's state of health.A biomérieux internal investigation has been initiated.Note: reference 30125 is not registered in the united states.The u.S.Similar device is product reference 30125-01.

Manufacturer Narrative

An internal investigation was performed following a notification from a customer from korea that they obtained a false negative results on a patient sample when testing with vidas® gdh ref 30125 lot: 1009166990.Investigation: 1.Device history record.The analysis of the batch history record for the vidas gdh ref 30125 lot: 1009166990 showed no anomaly during the manufacturing, control and packaging processes.No non-conformity nor capa linked to the customer¿s complaint vidas gdh ref 30125 lot: 1009166990.2.Complaint analysis.The complaint analysis did not reveal this issue as a systemic quality issue.3.Tests/analysis performed.The user does not respect the pre-analytical recommendations of the package insert for vidas gdh and cdab.The natives stool are not stable for a return.Control charts analysis: the analysis of the control charts performed on 3 internal samples (targeted at 0.27, 1.01 and 4.56 tv) and 6 batches including customers¿ batch: 1009166990 showed that all results are within specifications.Customer¿s batch is in the trend compared to the other lots.The complaints laboratory tested an internal sample positive targeted at 0.60 tv on retain kit vidas gdh ref 30125 lot: 1009166990.The result obtained is within the acceptable ranges.An evolution did not observed over time of the kit.Root cause identified at customer's level: the customer does not respect the preanalytical of the package insert for vidas gdh and cdab so the result cannot be valid.This is an operator error.First, the volume of diluent does not comply to the package insert specification: 200 l instead of 1000 l.Second, the customer collects twice in the supernatant / this is not validated.The user has to perform two different extractions for vidas gdh and vidas cdab.4.Root cause analysis and conclusion.According to all information above, no anomaly was highlighted with the control chart analysis, the analysis of quality data and the test performed on the retain kit vidas gdh ref 30125 lot: 1009166990 using internal sample material.In addition, the complaints laboratory did not reproduce the false negative result with vidas gdh ref 30125 lot: 1009166990 observed by the customer on internal sample.Therefore the main hypothesis is a preanalytical issue at customer¿s level.According to the above data, vidas gdh ref 30125 lot: 1009166990 is within the expected performances.

• Brand Name: VIDAS® C. DIFFICILE GDH
• Type of Device: VIDAS® C. DIFFICILE GDH
• Manufacturer (Section D): BIOMERIEUX SA; 376 chemin de l'orme; marcy l'étoile 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX SA; 376 chemin de l'orme; marcy l'étoile 69280 ; FR 69280
• Manufacturer Contact: ines el oueryemmi ; 5 rue des acqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 15125064
• MDR Text Key: 301136739
• Report Number: 8020790-2022-00088
• Device Sequence Number: 1
• Product Code: MCB
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K132010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2023
• Device Catalogue Number: 30125
• Device Lot Number: 1009166990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2022
• Initial Date FDA Received: 07/28/2022
• Supplement Dates Manufacturer Received: 08/24/2022
• Supplement Dates FDA Received: 09/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1